BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Hemostasis, Vascular

    PMA: P040044 · Supplement: S097 · Decision Jun 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33

    Basic Information

    Device Name
    Device, Hemostasis, Vascular
    Trade Name
    MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F
    PMA Number
    P040044
    Supplement Number
    S097
    Device Class
    FDA Class 3
    Product Code
    MGB
    Generic Name
    Device, hemostasis, vascular
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 27, 2024
    Date Received
    November 30, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    24M-3091

    Advisory Committee Statement

    Approval for the MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F for expanding the indications to include venous multiple access closure.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGB Device, Hemostasis, Vascular